VENOFER SOLUTION FOR INJECTION 100 mg5 ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

IRON EQV IRON SUCROSE

Available from:

VIFOR PHARMA ASIA PACIFIC PTE. LTD.

ATC code:

B03AC

Dosage:

100 mg/5 ml

Pharmaceutical form:

INJECTION

Composition:

IRON EQV IRON SUCROSE 100 mg/5 ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

IDT Biologika GmbH

Authorization status:

ACTIVE

Authorization date:

2000-07-20

Summary of Product characteristics

1.
Trade Name of the Medicinal Product
Venofer
2.
Qualitative and Quantitative Composition
Each 5 ml ampoule contains 20 mg/ml iron as iron sucrose corresponding
to 100 mg iron per ampoule.
For the full list of excipients, see section 6.1.
3.
Pharmaceutical Form
Solution for injection or concentrate for solution for infusion.
Venofer is a dark brown, non transparent, aqueous solution with a pH
of 10.5 – 11.0 and
an osmolarity of 1250 mOsmol/l.
4.
Clinical Particulars
4.1
Therapeutic indications
Venofer is indicated for the treatment of iron deficiency in the
following indications:

Where there is a clinical need for a rapid iron supply

In patients who cannot tolerate oral iron therapy or who are
non-compliant

Where oral iron preparations are ineffective (e.g., in active
inflammatory bowel disease)
Venofer should only be administered where the indication is confirmed
by appropriate investigations.
4.2
Posology and method of administration
Monitor carefully patients for signs and symptoms of hypersensitivity
reactions during and following each
administration of Venofer.
Venofer should only be administered when staff trained to evaluate and
manage anaphylactic reactions is
immediately available, in an environment where full
resuscitation facilities can be assured. The patient should be
observed for adverse
effects for at least 30 minutes following each Venofer injection.
Posology
The cumulative dose of Venofer must be calculated for each patient
individually and must not be exceeded.
Calculation of dosage
The total cumulative dose of Venofer, equivalent to the total iron
deficit (mg), is determined by the
haemoglobin level (Hb) and body weight (BW). The dose of Venofer must
be individually calculated for
each patient according to the total iron deficit calculated with the
following Ganzoni formula, for example:
Total iron deficit [mg] = BW [kg] x (target Hb - actual Hb) [g/dl] x
2.4* + storage iron [mg]
Below 35 kg BW:
Target Hb = 13 g/dl and storage iron = 15 mg/kg BW
35 kg BW and above:
Target Hb = 15